Mechanism of Support. This RFA will utilize the U01
cooperative agreement grant mechanism.

Funds Available and
Anticipated Number of Awards. $25 million available to support 15-20 awards.
Awards issued under this RFA are contingent upon the availability of funds
and the submission of a sufficient number of meritorious applications.
Because the nature and scope of the proposed research will vary from application
to application, it is anticipated that the size and duration of each award
will also vary.

Budget and Project Period. The annual direct costs that
can be requested are not limited but must be justified by the proposed
research and will be evaluated by the review panel and program staff. The
total project period for an application submitted in response to this
funding opportunity may not exceed 5 years. At this time, it is not known
if competing renewal (formerly “competing continuation”)
applications will be accepted and/or if this FOA will be reissued.

Eligible Institutions/Organizations. Eligible
organizations include:

For-profit or non-profit organizations

Public or private institutions, such as
universities, colleges, hospitals, and laboratories

Units of U.S. state and local
governments

Eligible agencies of the U.S. Federal
government

Domestic or foreign

Faith-based or
community-based organizations

Eligible Principal
Investigators (PIs). Individuals with the skills, knowledge, and resources necessary
to carry out the proposed research are invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.

Number of Applications. Applicants may submit more
than one application, provided each application is scientifically
distinct.

The National Institute of Allergy and Infectious
Diseases (NIAID), National Institutes of Health (NIH), supports extramural
research focused on understanding, controlling and preventing diseases caused
by virtually all infectious agents. In response to growing concerns about
bioterrorism and emerging infectious diseases, the NIAID Division of
Microbiology and Infectious Diseases (DMID) has expanded research programs to
facilitate development of countermeasures for select pathogens and toxins.

Through this RFA, the NIAID invites research
applications for projects that will lead to the development of new vaccines,
adjuvants, therapeutics, immunotherapeutics or medical diagnostics focused on
NIAID Category A, B, or C priority pathogens and toxins (http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm).
Research may include, but is not limited to, target identification (e.g.,
compound screenings, epitope identification); the adaptation of platform
technologies or products to biodefense applications; optimization of products;
process development, early validation and testing; preclinical evaluation;
scale-up, and production of quantities sufficient for preclinical regulatory
requirements and suitable for clinical Phase I testing or field trials.
Applications that include collaborations between researchers from different
disciplines and/or with industry (e.g., pharmaceutical, chemical or
biotechnological companies) are strongly encouraged.

The NIAID recognizes that the inherent nature and
demands of the product development process may require funding large, complex
grants with interdependent specific aims. Furthermore, some aspects of the
product development process (e.g., Good Laboratory Practice [GLP] or current
Good Manufacturing Practice [cGMP] production) are inherently not innovative.
Recognizing that product development is often an iterative and sequential
process, and that steps early in the process may not be successful and may need to be modified or
reworked, NIAID staff, through the cooperative agreement grant mechanism, will
be actively involved in evaluating the milestones of awardees and determining
whether continued investment in the development is warranted.

NOTE: While
clinical development strategies may be included within an overall product development
plan, this RFA will NOT support clinical trials; applications requesting
support for clinical trials will be viewed as unresponsive to this RFA and will
be returned to the applicant without review. Utilization of human derived
material in pre-clinical studies in support of complying with regulatory
requirements is considered responsive.

NOTE: This
RFA will NOT support research on environmental or workplace detection
technologies or targets. Diagnostics applications must focus on the goal of
detection and identification of NIAID Category A, B or C priority pathogens or
toxins in human clinical samples.

Partnerships

A key component of this initiative is the development
of partnerships between academic researchers from different disciplines or with
industry. For the purpose of this RFA, "industry" is defined as large
and small, domestic or foreign, pharmaceutical, biotechnology, bioengineering,
and chemical companies. Since academic organizations are often the source of
new candidate products, this RFA will also support a partnership between
industry and collaborator(s) as necessary from academic and non-profit research
organizations. Partnerships between academic or non-profit research
organizations and industry are strongly encouraged, but not required.

The Principal Investigator of the project may be
affiliated with industry, an academic organization or non-profit research
organization.

To meet the objectives outlined by the Blue Ribbon
Panels, it is imperative that promising findings are translated rapidly into
new approaches and strategies for product development. The involvement of
experts from diverse disciplines (e.g., biochemists, structural biologists,
protein chemists, pharmacologists, immunologists, molecular biologists,
engineers and clinicians) within academia and industry in applied research and
product development is needed to bring sufficient knowledge to bear on the
development of well-designed candidates for vaccines, adjuvants, therapeutics,
immunotherapeutics, and medical diagnostics.

Research Goals and Objectives

The objective of this RFA is to support research that
will advance the development of vaccines, adjuvants, therapeutics,
immunotherapeutics, and medical diagnostics that are specific for NIAID
Category A, B, or C priority pathogens or toxins. Research is not required to
result in a "final" product but must advance the development of a
candidate product.

A second objective of this RFA is to stimulate
scientifically sound, original, and innovative research requiring a
comprehensive team and multidisciplinary effort that is likely to advance
promising candidate products or platform technologies through the product
development pathway. Applications proposing the development of a previously
identified candidate vaccine, therapeutic, adjuvant, or diagnostic product that
has demonstrated proof-of-concept against any of the NIAID Category A, B, or C
priority pathogens or toxins are strongly encouraged.

NOTE: While clinical development strategies may be
included within an overall product development plan, this RFA will NOT support
Phase I, II, and III clinical trials or field trials. Applications requesting
support for clinical trials will be viewed as unresponsive to this RFA and will
be returned to the applicant without review. However, utilization of appropriate
human cell lines and human derived material in pre-clinical studies in support
of complying with regulatory requirements is considered responsive and is
encouraged.

NOTE: This RFA will NOT support research on
environmental or workplace detection technologies or targets. Diagnostics
applications must focus on the goal of detection and identification of NIAID
Category A, B or C priority pathogens or toxins in human clinical samples.

Vaccines For Biodefense

Vaccines are the most effective method of protecting
the public against infectious diseases. The development of vaccines against
biological threat agents that can be administered quickly and can safely elicit
a protective response in a broad range of recipients is a high priority.
Applications for vaccines against any of the NIAID Category A, B, or C
pathogens or toxins are invited. Approaches should consider the ultimate
potential of candidate vaccines to quickly induce safe and protective responses
in a diverse civilian population. Projects may include, but are not limited to,
one or more of the following areas:

Identification
and validation of protective epitopes for the development of recombinant or
subunit vaccine candidates;

Process
development for the production of vaccine components, including Quality
Assurance (QA)/Quality Control (QC), methods for product recovery,
characterization, purification, identity, stability, etc.;

Manufacturing
under GLP or cGMP to provide quantities sufficient for pre-clinical and early
clinical evaluation;

Optimization
of dose and route of delivery in pre-clinical evaluation;

Evaluation
of efficacy in challenge models where appropriate animal models are available;

Optimization
of production methodology including process development;

Scale
up and production of candidate vaccines including cGMP production;

Evaluation
of vaccine candidates, formulated with or without adjuvants or
immunomodulators, against a NIAID Category A, B, or C priority pathogen or
toxin; and

Performing
pre-clinical testing for safety, toxicity, and efficacy in animal models and
other benchmarks required for successful submission and review of an Investigational
New Drug (IND) application by the Food and Drug Administration (FDA) (http://www.fda.gov/cber/vaccine/vacappr.htm).

NOTE: Applications proposing the development of a
vaccine that does not focus on a NIAID Category A, B, or C priority pathogen or
toxin will be deemed unresponsive and will be returned to the applicant without
review.

NOTE: Clinical trials for vaccines will NOT be
supported.

NOTE: For applications involving vaccine development
for Bacillus anthracis, of particular interest are projects involving the
development of vaccines that affect the persistence, germination, clearance,
and inactivation (host immune response mechanisms) of spores in the lung and/or
mediastinal lymph nodes.

NOTE: For applications directed towards vaccine
development, of particular interest, especially for Category A agents, are
projects incorporating non-needle vaccine delivery systems, such as
transdermal, oral, or nasal delivery, as well as formulation methodologies that
obviate the need for cold-storage of the resulting product.

NOTE: For applications involving vaccine development
for Category B bacterial pathogens, of particular interest are projects focused
on development of vaccines for Burkholderia mallei, Burkholderia
pseudomallei, Coxiella burnetti, and Rickettsia prowazekii.

NOTE: For applications for bacterial food and
waterborne pathogens, of particular interest are projects using genomics and
proteomics to identify cross-reactive, protective antigens for the development
of vaccine candidates to Shigella spp., enterotoxigenic E. coli (ETEC), or cholera.

Adjuvants For Biodefense

The development of an enhanced immune response may
require the administration or co-administration of an adjuvant or
immunostimulatory compound. Applications for development of novel adjuvants
that could be used in conjunction with specific pathogen components are
invited. Adjuvants are broadly separated into two classes based upon their
primary mechanism of action: vaccine delivery systems (e.g., emulsions,
microparticles, iscoms, and liposomes) that target associated antigens to
antigen presenting cells, and immunostimulatory adjuvants (e.g., LPS, MLP, or
CpG DNA) that directly activate innate immune responses. In order to advance
the development of vaccine adjuvants against NIAID Category A, B, or C priority
pathogens and their toxins, this solicitation focuses on optimization and
preclinical testing of prospective lead compounds that previously showed
promise in early stages of discovery and development. Projects may include, but
are not limited to, one or more of the following areas:

Identification
and analysis of lead compounds with a high potential as adjuvant candidates
based upon their antigen targeting capability, receptor binding capacity, and
effect on immune signaling;

Optimization
of dose, dosing interval, and route of delivery in pre-clinical evaluation;

Process
development for the manufacturing of adjuvant components, including QA/QC
methods for product recovery, characterization, purification, identity,
stability etc.;

Scale-up
under GLP or cGMP to provide sufficient quantities for preclinical FDA-required
animal studies and Phase I clinical trials;

GLP or
cGMP production; and

Performing
pre-clinical testing for safety and efficacy in animal models and other
benchmarks required for successful submission and review of an IND application by the FDA (http://www.fda.gov/cber/index.html)
or for moving into Phase I clinical trials.

NOTE:
Clinical trials for adjuvants will NOT be supported.

Therapeutics For Biodefense

The need for safe and effective antimicrobials for
biodefense against threats by highly pathogenic agents or their toxins is a key
national priority. Applications for development of drugs against any NIAID
Category A, B, or C priority pathogens and toxins are invited, with particular
interest in therapeutics with broad spectrum activity or those that address
antimicrobial resistance. Projects may include, but are not limited to, one or
more of the following areas:

Identification
and validation of new targets for drug discovery or development of previously
identified targets for drugs by examining microbial gene products expressed
during infection and/or host gene products expressed as a consequence of
infection;

NOTE: Applications proposing the development of a
therapeutic that does not focus on a NIAID Category A, B, or C priority
pathogen or toxin will be deemed unresponsive and will be returned to the
applicant without review.

NOTE: Clinical trials for therapeutics will NOT be
supported.

NOTE: For applications involving development of
therapeutics for Bacillus anthracis, of particular interest are projects
involving the development of therapeutics that affect the persistence,
germination, clearance, and inactivation (host immune response mechanisms) of
spores in the lung and/or mediastinal lymph nodes.

NOTE: For applications involving development of
therapeutics, of particular interest are projects that incorporate formulation
strategies that provide for extended shelf-life properties of the resulting
product.

NOTE: For applications involving therapeutic
development for Category B bacterial pathogens, of particular interest are
projects focused on development of vaccines for Burkholderia mallei, Burkholderia
pseudomallei, Coxiella burnetti, and Rickettsia prowazekii.

NOTE: Discovery and development of novel post-exposure
treatments for the botulinum neurotoxins, ricin, Shiga toxins, and Staphylococcal
enterotoxin B (SEB) are of particular interest, especially interventions that
can reverse or block the effects of intoxication after the toxins have reached
their intracellular site of action.

Immunotherapeutics For Biodefense

Applications to discover and/or improve immune-based
therapeutics including both broad-spectrum (innate immunity) and pathogen or
toxin-specific (antibodies) are invited. Major objectives for products
generated in this research program include prevention of infection or intoxication
in the face of an immediate threat, protection of immunocompromised
individuals, and post-exposure treatment to suppress infection and disease.
Projects focused on compounds that directly affect pathogens/toxins and/or
approaches to stimulate non-specific immunity are encouraged. Passive
treatments may be especially valuable during the acute emergence of infectious
diseases and may complement the use of antimicrobial drugs or vaccination
programs to optimize protection. Projects may include, but are not limited to,
one or more of the following areas:

NOTE: For applications involving development of
immunotherapeutics for Bacillus anthracis, of particular interest are
projects involving the development of immunotherapeutics that affect the
persistence, germination, clearance, and inactivation (host immune response
mechanisms) of spores in the lung and/or mediastinal lymph nodes.

NOTE: For applications involving development of
immunotherapeutics for Category B bacterial pathogens, of particular interest
are projects focused on development of immunotherapeutics for Burkholderia
mallei, Burkholderia pseudomallei, Coxiella burnetti, and Rickettsia
prowazekii.

NOTE: Discovery and development of novel post-exposure
immunotherapeutics for the botulinum neurotoxins, ricin, Shiga toxins, and SEB
are of particular interest, especially interventions that can reverse or block
the effects of intoxication after the toxins have reached their intracellular
site of action.

Diagnostics for Biodefense

There is an urgent need for rapid, highly sensitive,
specific, easy to use, adaptable, and cost-effective medical diagnostics for
public health laboratories, hospital-based clinical laboratories, and
point-of-care use to diagnose individuals exposed to and/or infected with NIAID
Category A, B, or C priority pathogens or their toxins. Diagnostics are needed
to identify infectious agents or toxins in clinical samples from individuals
that are pre- symptomatic, symptomatic, or have non-specific symptoms so
appropriate therapeutic intervention or containment can be executed. Medical
diagnostics that use platforms to simultaneously detect multiple pathogens in
clinical specimens to rapidly distinguish whether an individual is infected by
a biological threat agent or a common infection with similar, generalized
symptoms and determine drug sensitivities are of high priority.

Applications for applied research or advanced product
development for medical diagnostics, including both technology and assay
development specific for NIAID Category A, B, or C pathogens and toxins are
invited. Projects may include, but are not limited to, one or more of the
following areas:

Technologies
and assays demonstrating the highest performance of specificity, sensitivity,
rapidity, and cost-effectiveness when applied to relevant clinical samples to
detect an infectious agent and/or toxin;

Technologies
that integrate multiple methods of parallel measurements for detection in the
same platform, such as detecting nucleic acids, proteins and other targets from
multiple agents in the same assay;

Technologies
for multiplex, rapid nucleic acid or antigen detection using novel and improved
methodologies and reagents;

Technologies
capable of resolving engineered or otherwise acquired genetic traits in
microorganisms, such as patterns of microbial resistance or enhanced virulence;

Methods
for rapid sample preparation, processing, and concentration;

Methods
capable of high throughput, robotics, and automated data output and analyses;

In vivo
imaging methods and development of contrast reagents for visualization of
pathogens or host immune responses in vivo ; and

Process
development for the manufacturing of diagnostic components, including QA/QC
methods for reagent recovery, characterization, purification, identity, and
stability;

NOTE: Applications proposing the development of a
diagnostic that does not focus on a NIAID Category A, B, or C priority pathogen
or toxin will be deemed unresponsive and will be returned to the applicant
without review.

NOTE: This program will NOT support research on the
development of environmental detection devices or their deployment. As such,
applications for the development of environmental detection devices and/or
their deployment will be deemed unresponsive and returned to the applicant
without peer review.

NOTE: For applications involving development of
diagnostics for Category B bacterial pathogens, of particular interest are
projects focused on development of diagnostics for Burkholderia mallei, Burkholderia
pseudomallei, Coxiella burnetti, and Rickettsia prowazekii.

Section II. Award Information

1. Mechanism(s) of Support

This
funding opportunity will use theU01 cooperative
agreementaward
mechanism.As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project.

This
funding opportunity uses the just-in-time budget concepts. It also uses the
non-modular budget format described in the PHS 398 application instructions
(see https://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.

The NIHU01is a cooperative agreement award
mechanism. In the cooperative agreement mechanism, the Principal Investigator
retains the primary responsibility and dominant role for planning, directing,
and executing the proposed project, with NIH staff being substantially involved
as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements,
"Cooperative Agreement Terms and Conditions of Award".

Essential
elements of the U01 include: (1) a single research project that may include
consortium agreements, but does not include "Core" resources and
facilities as defined for U19 applications; (2) a single Principal Investigator
who will be scientifically and administratively responsible for the research
project; and (3) a single applicant institution that will be legally and
financially responsible for the use and disposition of funds awarded.

This RFA is a one-time solicitation. At this time, the
NIAID has not determined whether or how this solicitation will be continued
beyond the present RFA.

2. Funds Available

The NIAID intends
to commit approximately $25 million dollars in fiscal year (FY) 2008 to fund 15-20new and/or competitive
continuation grants in response to this RFA. An applicant may request a
project period of up to five years. Because the nature and
scope of the proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary. Although
the financial plans of the IC(s) provide support for this program, awards
pursuant to this RFA are contingent upon the availability of funds and the
receipt of a sufficient number of meritorious applications.

The
annual direct costs that can be requested are not limited but must be justified
by the proposed research and will be evaluated by the review panel and program
staff. Applicants may request up to a total of $300,000 in first-year costs for
major equipment to ensure that research aims can be met and biohazards can be
contained. Prior approval from program staff, listed below under Section
VII. Agency Contact(s), must be obtained for requests for equipment that
exceed this amount. Unapproved equipment requests that exceed $300,000 will not
be considered for funding.

Facilities
and administrative costs requested by consortium participants are not included
in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You
may submit (an) application(s) if your organization has any of the following
characteristics:

Eligible
organizations include:

For-profit or
non-profit organizations

Public
or private institutions, such as universities, colleges, hospitals, and
laboratories

Units
of U.S. state and local governments

Eligible
agencies of the U.S. Federal government

Domestic
or foreign

Faith-based or community-based organizations

Institutions
must be in compliance with U.S. laws and regulations and DHHS and NIH policies
in effect at the time of grant award and during the period of performance of
the research.

1.B. Eligible
Individuals

Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with their institution to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.

Applications
must be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a D&B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number
should be entered on line 11 of the face page of the PHS 398 form.

The title and number
of this funding opportunity must be typed on line 2 of the face page of the
application form and the YES box must be checked.

Foreign Organizations

Several special
provisions apply to applications submitted by foreign organizations:

Charge back of customs and import fees is not
allowed.

Format: every effort should be made to comply with
the format specifications, which are based upon a standard US paper size of 8.5" x 11."

Organizations must comply with federal/NIH policies on
human subjects, animals, and biohazards.

Organizations must comply with federal/NIH biosafety
and biosecurity regulations. See Section VI. 2.
Administrative Requirements, "Administrative and National Policy
Requirements".

Applications
from foreign (non-U.S.) institutions submitted using the PHS 398: Follow the NON-MODULAR FORMAT
instructions and submit Form Page 4 and Form Page 5. Do not complete or submit
the Modular Budget Format Page.

Proposed research
should provide special opportunities for furthering research programs through
the use of unusual talent, resources, populations, or environmental conditions
in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

Applications
must be received on or before the receipt date described below (Section IV.3.A)

Prospective
applicants are asked to submit a letter of intent that includes the following
information:

Descriptive title of proposed research

Name, address, and telephone number of the Principal
Investigator

Names of other key personnel

Participating institutions

Number and title of this funding opportunity

Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at
the beginning of this document.

Applications
must be prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, andthreesigned
photocopies in one package to:

Using the RFA Label: The RFA label available in the PHS
398 application instructions must be affixed to the bottom of the face page of
the application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title and
number must be typed on line 2 of the face page of the application form and the
YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application
Processing

Applications
must be received on or before the application receipt date(s) described
above (Section IV.3.A.). If an application is
received after that date, it will be returned to the applicant without review.
Upon receipt, applications will be evaluated for completeness by the CSR and
responsiveness by theNIAID.Incomplete and non-responsive
applications will not be reviewed.

The
NIH will not accept any application in response to this funding opportunity
that is essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity must not include an Introduction describing the changes and
improvements made, and the text must not be marked to indicate the changes from
the previous unfunded version of the application.

All
NIH awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

Pre-award
Costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or competing
continuation award if such costs: are necessary to conduct the project, and
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new or competing continuation award.

The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Research Plan

1. Research Focus

This program responds to
the urgent public health need to develop new and promising products for
biodefense by supporting partnerships between the research community and the
Federal Government. Each application must propose a research and development
project whose goal is to advance a countermeasure (vaccine, adjuvant,
therapeutic, immunotherapeutic or diagnostic) specific for an NIAID Category A,
B or C priority pathogen or toxin through the product development process. It
is not necessary to propose to complete the product development process up to
the point of readiness for clinical trials within the time frame of this
project. Applications that would significantly advance a specific product
toward clinical or field usefulness are responsive.

NOTE: All applications
for research projects focused on diagnostics should include in the Research
Plan:

A clear
description of the capabilities of the method, technology or assay;

A clear
description of how the diagnostic/technology will be used; and

Plans
for determining the sensitivity, specificity and validation of the technology,
assay or diagnostic

2. Mandatory Meetings

Requested budgets must include
funds for travel by the Principal Investigator and key personnel to an annual
meeting in Bethesda, Maryland (USA), or at a relevant scientific meeting, as
determined by NIAID Program staff. See Section VI.2.A.1. Award Administration
Information below.

3. Major Equipment

Applicants may request up
to a total of $300,000 for major equipment to ensure that research aims can be
met and biohazards can be contained. Funds for equipment must be included in
the first year requested budget with justification. Prior approval from program
staff, listed below in Section VII. Agency Contact(s), must be obtained for
requests for equipment that exceed this amount. Unapproved equipment requests
that exceed $300,000 will not be considered for funding.

4. Good Laboratory
Practice

When appropriate,
applicants must document in the Research Plan compliance with guidelines that
govern GLP, as defined by 21 CRF (58), and cGMP, as defined by 21 CRF (211),
manufacturing and/or IND/IDE enabling studies that will be performed under the
project award as they would be applicable to eventual product licensure in the U.S.

5. External Advisors

External advisors may be
appointed by the Principal Investigator in consultation with NIAID Program
Staff to assist in progress review. Names of suggested external advisors should
NOT be included in the application or in the (optional) letter of intent;
external advisors should be identified and appointed only after award.

Applicants must provide
detailed project performance and timeline objectives in a section entitled
“Milestones and Timeline” (may not exceed 5 pages). The Milestones
and Timeline section should follow the Research Plan of the application and
does not count towards the page limits for the Research Plan. This section must
include:

A clear
description of all interim objectives (developmental milestones) to be achieved
during the course of the project. Applicants also must identify any impediments
that could require a revision in the work plan or milestones with a discussion
of alternative approaches.

Detailed
quantitative criteria by which milestone achievement will be assessed.

A
detailed schedule or timeline for the anticipated attainment of each milestone
and the overall goal(s).

Patent
status or other protection of project intellectual property.

2. Product Development
Plan

Applicants must include a
section entitled “Product Development Plan” in the application (may
not exceed 5 pages). The Product Development Plan should follow the Milestones
and Timeline section of the application and does not count towards the page
limits for the Research Plan. This section must include:

A
statement of the value of the project, including lay description of key
technology objectives, current competition, and advantages compared to
competing products, technologies, or services.

A clear
description of the goal(s) of the project, including one (or more) final
product(s) or stage(s) of product development to be completed during the award
period. A specific product profile that is defined by licensing indication is
not requested.

A clear
description of plans for further commercial development of candidate product(s)
after completion of this project.

3. Physical and/or
Facility Security

Applicants must address
issues related to physical or facility security and biocontainment and
biosafety (http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm)
pertinent to the specific pathogens of interest in a section entitled
“Biosafety and Biocontainment” in the application (may not exceed 1
page). Guidelines for Institutional Biosafety Committees are available at: http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm.
The Biosafety and Biocontainment section should follow the Product Development
Plan section of the application and does not count towards the page limits for
the Research Plan.

Plan for Sharing Research
Data

The
precise content of the data-sharing plan will vary, depending on the data being
collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected
schedule for data sharing, the format of the final dataset, the documentation
to be provided, whether or not any analytic tools also will be provided,
whether or not a data-sharing agreement will be required and, if so, a brief
description of such an agreement (including the criteria for deciding who can
receive the data and whether or not any conditions will be placed on their
use), and the mode of data sharing (e.g., under their own auspices by mailing a
disk or posting data on their institutional or personal website, through a data
archive or enclave). Investigators choosing to share under their own auspices
may wish to enter into a data-sharing agreement. References to data sharing may
also be appropriate in other sections of the application.

Applicants
requesting more than $500,000 in direct costs in any year of the proposed
research must include a plan for sharing research data in their application.
The funding organization will be responsible for monitoring the data sharing
policy (https://grants.nih.gov/grants/policy/data_sharing).

The
reasonableness of the data sharing plan or the rationale for not sharing
research data may be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.

The
adequacy of the resources sharing plan and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each
non-competing Grant Progress Report (PHS 2590, https://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.

Section
V. Application Review Information

1. Criteria

Only
the review criteria described below will be considered in the review process.

The
following will be considered in making funding decisions:

Scientific
merit of the proposed project as determined by peer review

Availability
of funds

Relevance
of program priorities

2. Review and Selection Process

Applications
that are complete and responsive to the RFA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by NIAID in
accordance with the review criteria stated below.

As
part of the initial merit review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score.

Receive
a written critique.

Receive
a second level of review by the National Advisory
Allergy and Infectious Diseases Council.

The goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and to
enhance health. In their written critiques, reviewers will be asked to comment
on each of the following criteria in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

Significance: Does this
study address an important problem? If the aims of the application are
achieved, how will scientific knowledge or clinical practice be advanced? What
will be the effect of these studies on the concepts, methods, technologies,
treatments, services, or preventative interventions that drive this field?Is this project likely to significantly advance the
development of a vaccine, adjuvant, therapeutic, or diagnostic against the
specific biologic threat agent identified in this initiative? If the aims of
the application are achieved, are important biomedical agents or products
likely to result? What will be the effect of these studies on the concepts or
methods that drive this field?

Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? Is the likelihood of successful project completion high given the
current state of research and development and the technical approach? Are the
proposed timeline and interim milestones appropriate, feasible and technically
sound?

Innovation: Is the
project original and innovative? For example: Does the project challenge
existing paradigms or clinical practice; address an innovative hypothesis or
critical barrier to progress in the field? Does the project develop or employ
novel concepts, approaches, methodologies, tools, or technologies for this
area?Many aspects of vaccine, adjuvant,
therapeutics, immunotherapeutics, and diagnostics product development are not
inherently innovative: In each project, does the proposed research
leverage multi-disciplinary involvement to accelerate product
development? In addition, does the approach represent the best use of
current or emerging technologies and appropriate collaborations to achieve the
research objectives?

Investigators: Are the
investigators appropriately trained and well suited to carry out this work? Is
the work proposed appropriate to the experience level of the principal investigator
and other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?

Environment: Does the
scientific environment in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?

Milestones
and Product Development Plan: Are the defined objectives/milestones and future
product development plan appropriate and feasible? Are the plans and rationale
for conducting preclinical testing for safety and efficacy in animal
models appropriate and feasible?

2.A. Additional
Review Criteria:

In
addition to the above criteria, the following items will continue to be
considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The
involvement of human subjects and protections from research risk relating to
their participation in the proposed research will be assessed (see the Research
Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion
of Women, Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals of
the research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated (see the Research Plan, Section E on Human
Subjects in the PHS Form 398).

Care and
Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five items described
under Section F of the PHS Form 398 research grant application instructions
will be assessed.

Biohazards: If
materials or procedures are proposed that are potentially hazardous to research
personnel and/or the environment, determine if the proposed protection is
adequate.

2.B. Additional Review
Considerations

Budget: The
reasonableness of the proposed budget and the requested period of support in
relation to the proposed research. The priority score should not be affected by
the evaluation of the budget.

2.C. Sharing Research Data

Data
Sharing Plan: The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score. The funding
organization will be responsible for monitoring the data sharing policy. https://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research
Resources

NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators
responding to this funding opportunity should include a sharing research
resources plan addressing how unique research resources will be shared or
explain why sharing is not possible. Program staff will be responsible
for the administrative review of the plan for sharing research resources.

The
adequacy of the resources sharing plan will be considered by Program staff of
the funding organization when making recommendations about funding
applications. Program staff may negotiate modifications of the data and
resource sharing plans with the awardee before recommending funding of an
application. The final version of the data and resource sharing plans
negotiated by both will become a condition of the award of the grant. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590).
See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

Not applicable

Section
VI. Award Administration Information

1. Award Notices

After
the peer review of the application is completed, the PD/PI will be able to
access his or her Summary Statement (written critique) via the eRA Commons.

A formal
notification in the form of a Notice of Award (NoA) will be provided to
the applicant organization. The NoA signed by the grants management officer is
the authorizing document. Once all administrative and programmatic issues have
been resolved, the NoA will be generated via email notification from the
awarding component to the grantee business official (designated in item 12 on
the Application Face Page). If a grantee is not email enabled, a hard copy of
the Notice of Award will be mailed to the business official.

Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

The
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.

2.A. Cooperative
Agreement Terms and Conditions of Award

The
following special terms of award are in addition to, and not in lieu of, otherwise
applicable OMB administrative guidelines, HHS grant administration regulations
at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local
Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies.

The administrative
and funding instrument used for this program will be the cooperative agreement
(U01), an "assistance" mechanism (rather than
an "acquisition" mechanism), in which substantial NIH programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the NIH purpose is to support and
stimulate the recipients' activities by involvement in and otherwise working
jointly with the award recipients in a partnership role; it is not to assume
direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

The
Principal Investigator will have the primary responsibility for:defining the research objectives, approaches and
details of the projects within the guidelines of the RFA-AI-07-003 and for
performing the scientific activity. Specifically, awardees have primary
responsibility as described below.

The
Principal Investigator retains primary responsibility for the performance of
the scientific activity, and agrees to accept close assistance in coordination,
cooperation and participation of NIAID staff in scientific and technical
management of the project in accordance with the terms formally and mutually
agreed upon prior to the award. The responsibility for the planning, direction,
and execution of the proposed project will be solely that of the Principal
Investigator.

Intellectual
Property

The
successful development of high priority products for biodefense will require
substantial investment and support of private sector industries and may also
involve collaborations with multiple organizations, including academic and/or
non-profit research institutions. It is the intent of this initiative to
support the formation of the appropriate public-private partnerships that are
essential to meet these urgent public health needs. NIAID recognizes that
intellectual property rights are likely to play an important role in achieving
the goals of this program. To this end, all awardees understand and acknowledge
the following:

Awardee
is solely responsible for the timely acquisition of all proprietary rights,
including intellectual property rights, and all materials needed for applicant
to perform the project;

Before,
during, and subsequent to the award, the U.S. Government is not required to
obtain for applicant any proprietary rights, including intellectual property
rights, or any materials needed by applicant to perform the project;

Awardee
is required to report to the U.S. Government all inventions made in the performance
of the project, as specified at 35 U.S.C. Sect. 202 (Bayh-Dole Act).

Awardees
are encouraged to reach early consensus with their proposed partners regarding
intellectual property and other legal matters that may arise during the
project. In addition, awardees are expected to exercise their Bayh-Dole rights
in a manner that does not conflict with the goals of this award or the intent
of the Bayh-Dole Act to promote the utilization, commercialization and
availability of U.S. Government-funded inventions for public benefit. Finally,
awardees are expected to make new information and materials known to the
research community in a timely manner through publications, web announcements,
and reports to the NIAID or other mechanisms.

The NIH
has established a new policy regarding the use of NIH funds for research
involving Select Agents. This policy is being implemented using Terms of Award
that are to be included in any grant, cooperative agreement, or contract in
which select agents are or will be used.

Award to
a U.S. Institution: This award includes research involving Select Agents (see
42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the
relevant animal and plant pathogens). Before using NIH funds, the awardee must
complete registration with CDC (or USDA, depending on the agent). No
funds can be used for research involving Select Agents if the final
registration certificate is denied.

Award to
Foreign Institution: This award includes research involving Select Agents (see
42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the
relevant animal and plant pathogens). Before using NIH funds for any work
directly involving the Select Agents, the awardee must provide information
satisfactory to the NIH that a process equivalent to that described in 42 CFR
73 for US institutions is in place and will be administered on behalf of all
Select Agent work sponsored by these funds. The awardee must be willing to
address the following key elements appropriate for their institutions: safety,
security, training, procedures for ensuring that only approved/appropriate
individuals have access to the Select Agents, and any applicable laws, regulations
and policies equivalent to 42 CFR 73.

Award to
U.S. Institution with Foreign Institution Participation: This award includes
research involving Select Agents (see 42 CFR 73 for the Select Agent list; and
7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens). Before
using NIH funds for any work directly involving the Select Agent at the US institution, the awardee must complete registration with CDC or USDA, depending on the
agent). No funds can be used for research involving Select Agents if the
final registration certificate is denied. Before using NIH funds for any work
directly involving the Select Agents at the foreign institution, the US awardee
must provide information from the foreign institution satisfactory to the NIH that
a process equivalent to that described in 42 CFR 73 for US institutions is in
place and will be administered on behalf of all Select Agent work sponsored by
these funds. The awardee must be willing to address the following key elements
appropriate for the foreign institution: safety, security, training, procedures
for ensuring that only approved/appropriate individuals have access to the
Select Agents, and any applicable laws, regulations and policies equivalent to
42 CFR 73.

Meetings

One
mandatory progress review meeting of the awardees will be held annually at the
NIAID, or at a site designated by the NIAID Program Official, during which the
Principal Investigator and appropriate Key Personnel will present significant
findings. The NIAID Program Official and External Advisors (when applicable)
will be present. A critical determinant of success will be the degree of
communication between the Principal Investigator, Project Leaders and other
significantly involved parties. Therefore, in addition to the one meeting
listed above, additional meetings, which may be necessary for coordination of
cooperative agreement activities, may be scheduled if justified. Regular
telephone and written communication with the NIAID Program Official is
considered to be very important and is strongly encouraged.

Publications

The
Principal Investigator will be responsible for the timely submission of all
abstracts, manuscripts and reviews (co)authored by members of the cooperative
agreement award and supported in part or in total under this Agreement. The
Principal Investigator and Project Leaders are requested to submit manuscripts
to the Program Official within two weeks of acceptance for publication so that
an up-to-date summary of program accomplishments can be maintained and joint
press conferences and press releases prepared. Publications or oral
presentations of work performed under this Agreement are the responsibility of
the Principal Investigator and appropriate Project Leaders and will require
appropriate acknowledgement of NIAID support. Timely publication of major
findings is encouraged.

Awardees
will retain custody of and have primary rights to the data and software developed
under these awards, subject to Government rights of access consistent with
current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIAID Project Scientist will have substantial
programmatic involvement that is above and beyond the normal stewardship role
in awards, as described below. The NIAID Project Scientist will serve as a
liaison/facilitator between the awardee, pharmaceutical and biotechnology
industries, and other government agencies (e.g., FDA, USDA, CDC), and will
serve as a resource of scientific and policy information related to the goals
of the awardee's research. The NIAID Project Scientist will facilitate
coordination of project activities during the course of the project.

The NIAID
Project Scientist will assist the awardee with access to other NIAID-supported
resources and services, including resources for preclinical development such as
animal models, screening facilities, standardized research reagents, and a
genomics resource center, where available.

Additionally,
an NIAID Program Official will be responsible for the normal scientific and
programmatic stewardship of the award and will be named in the award notice.
NOTE: will the same person be serving as Project Scientist and Program
Official? If yes, a conflict of management plan should be provided as part of
the justification memo.

2.A.3. Collaborative Responsibilities

The specific
timelines, interim objectives and funding levels agreed to by the awardee and
the NIAID shall be included in the terms and conditions of award. Given the
nature of product development, it is recognized that timelines and interim
objectives may require revision and renegotiation during the course of the
project period. The Principal Investigator and NIAID must agree to all such
revisions. Release of each funding increment by NIAID will be based on a NIAID
review of progress towards achieving the previously agreed upon interim
objective. Where scientifically appropriate, NIAID may ask awardees to
collaborate or cooperate with other NIAID-funded projects and/or US government
agencies, for example CDC, FDA, and/or USDA.

External Advisors

External
advisors may be appointed by the Principal Investigator in consultation with
Program Staff to assist in progress review. External advisors will be
identified and appointed only after award.

2.A.4. Arbitration Process

Any
disagreements that may arise in scientific or programmatic matters (within the
scope of the award) between award recipients and the NIH may be brought to
arbitration. An Arbitration Panel composed of three members will be convened.
It will have three members: a designee of the awardee, , one NIH designee, and
a third designee with expertise in the relevant area who is chosen by the other
two. This special arbitration procedure in no way affects the awardee's right
to appeal an adverse action that is otherwise appealable in accordance with PHS
regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:

Human Subjects Protection:Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the adequacy
of protection against these risks, the potential benefits of the research to
the subjects and others, and the importance of the knowledge gained or to be
gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data
and safety monitoring is required for all types of clinical trials, including
physiologic toxicity and dose-finding studies (phase I); efficacy studies
(Phase II); efficacy, effectiveness and comparative trials (Phase III).
Monitoring should be commensurate with risk. The establishment of data and
safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants (NIH
Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek
guidance from their institutions, on issues related to institutional policies
and local IRB rules, as well as local, State and Federal laws and regulations,
including the Privacy Rule. Reviewers will consider the data sharing plan but
will not factor the plan into the determination of the scientific merit or the
priority score.

Access to Research Data through the Freedom of Information Act:The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Sharing of Model Organisms:NIH
is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:It
is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities
of NIH staff and the extramural community. The policy continues to require for
all NIH-defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to conduct
analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:The
NIH maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.

Required Education on the Protection of Human Subject Participants:NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):Criteria
for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.

NIH Public Access Policy:NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov) at
PubMed Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.

NIH
is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public
Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.

Standards for Privacy of Individually Identifiable Health Information:The
Department of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002 . The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and
proposals for NIH funding must be self-contained within specified page
limitations. For publications listed in the appendix and/or Progress report,
internet addresses (URLs) must be used for publicly accessible
on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.

Healthy People 2010:The
Public Health Service (PHS) is committed to achieving the health promotion and
disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This PA is related to one or more
of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This program is described
in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/,
in the following citation: 93.856,
Microbiology and Infectious Diseases Research, and is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review. Awards
are made under the authorization of Sections 301 and 405 of the Public Health
Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42
CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH
Grants Policy Statement. The NIH Grants Policy Statement can
be found at https://grants.nih.gov/grants/policy/policy.htm.

The
PHS strongly encourages all grant recipients to provide a smoke-free workplace
and discourage the use of all tobacco products. In addition, Public Law
103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities
(or in some cases, any portion of a facility) in which regular or routine
education, library, day care, health care, or early childhood development
services are provided to children. This is consistent with the PHS mission to protect
and advance the physical and mental health of the American people.

Loan Repayment Programs:NIH
encourages applications for educational loan repayment from qualified health
professionals who have made a commitment to pursue a research career involving
clinical, pediatric, contraception, infertility, and health disparities related
areas. The LRP is an important component of NIH's efforts to recruit and retain
the next generation of researchers by providing the means for developing a
research career unfettered by the burden of student loan debt. Note that an NIH
grant is not required for eligibility and concurrent career award and LRP
applications are encouraged. The periods of career award and LRP award may
overlap providing the LRP recipient with the required commitment of time and
effort, as LRP awardees must commit at least 50% of their time (at least 20
hours per week based on a 40 hour week) for two years to the research. For
further information, please see: http://www.lrp.nih.gov.